Proposed Rule by CMS Would Wipe Out Critical Protections in Medicare Part D for People Living With Serious Mental Illness

On January 6, the Centers for Medicare and Medicaid Services (CMS) unveiled a proposed rule revising prior agency policy that required Part D plans to include on their formularies “all or substantially all” drugs within six classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants, antiretrovirals, and antineoplastics. This policy, known as the “six protected classes” policy, has been in effect since the inception of Part D and has enjoyed strong bipartisan support in Congress. The Affordable Care Act strengthened this policy in 2010 by codifying it in federal statute, while granting CMS the authority to specify what criteria it would use to identify protected classes.

In last week’s proposed rule, CMS laid out its new criteria for deciding whether a class of drugs should have protected status:

failure to receive the drug would result in the patient’s hospitalization, disability or death within 7 days (the timeframe for the current exceptions and appeals process); and

medications in that class are not interchangeable.

The new criteria excludes antidepressants and immunosuppresants from protected status beginning in 2015. Antipsychotics would lose protected status in 2016. CMS argued that many of the drugs within these classes are interchangeable and will not cause hospitalization if patients do not immediately take them upon receiving a prescription.

CMS determined that antipsychotics also fail to meet the new criteria; however, they will not immediately be excluded from protected status. CMS is soliciting comments on whether a transitional policy for antipsychotics is needed.

NAMI has long supported the six protected classes policy and preserving open access to all FDA-approved medications. The public comment period is open through March 7, 2014. NAMI will be submitting comments. NAMI will also circulate sample comments to state and local NAMI affiliates and others who wish to submit their own comments about this important policy issue in the Medicare Part D program.

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